Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
GN308
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Anaemia
Intervention
Patients are randomised to one of two treatment arms:
1. Arm A: Patients receive 150 IU/Kg of Epoetin alpha
2. Arm B: Patients receive matching placebo
Epoetin alpha or placebo is given subcutaneously three times per week for the first four weeks (or the first on-study chemotherapy cycle, respectively). Haemaglobin level and/or reticulocyte count will then be used to determine whether the same dose (volume) or a doubled dose (volume) will be used for the remainder of the treatment.
Intervention type
Other
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/01/2003
Overall study end date
01/01/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of non-myeloid malignancy, which requires non-platinum containing chemotherapy
2. Predicted chemotherapy of 12 to 24 weeks (three to six cycles) duration
3. Performance score zero to three
4. Life expectancy of more than six months
5. Aged over 18 years
6. Patients with acute leukaemia are excluded
7. No myeloablative chemotherapy
8. No uncontrolled hypertension
9. No evidence of untreated iron, folate or vitamin B12 deficiency
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/01/2003
Recruitment end date
01/01/2004
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Janssen-Cilag Ltd (UK)
Sponsor details
Saunderton
High Wycombe
HP14 4HJ
United Kingdom
+44 (0)1494 567567
Sponsor type
Industry
Website
http://www.janssen-cilag.co.uk
ROR
Funders
Funder type
Industry
Funder name
Janssen-Cilag Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|